Contacts: rory.o.carolan@usda.gov ; NVSL.Coggins@usda.gov

Approval of Laboratories to Conduct Testing for EIA - VSG 15201.1 

The Guidance was effective as of the 15 OCT 2019 release date. Clarifications as of December 2019 are noted in RED. This document 

seeks to explain the changes in the new guidance, reference where they can be found and highlight who is affected and how. Please 

consult the actual guidance document as the definitive source.

Requirement 

and

Rationale

New Guidance Location 

of 

Guidance

Who is affected? What actions are required?

Read, Sign & 

Return new 

Director’s 

Agreement

Acknowledge 

new 

requirements 

and regulatory 

obligations.

NVSL must receive a 

new, signed EIA 

Director’s 

Agreement that 

acknowledges 

receipt and an 

understanding of 

the requirements 

before it will make 

the annual 

proficiency test 

available to that 

laboratory.

6.L

• Approved EIA laboratories must read, sign and return a new Director’s Agreement.

• SAHO may assist in explaining new guidance, outreach and compliance efforts.

• AVIC may assist in explaining new guidance, outreach and compliance efforts.

Require the use 

of an official 

test form &

standardize the 

information 

contained 

therein.

The VS Form 10-11 

is the official 

Federal form and

serves as the 

reference standard 

for all other USDA 

approved forms. 

Revisions and 

4.C.2 • Owners may see a change in the form their veterinarian uses.

• Category II submitting veterinarians must obtain, accurately and fully complete the official form. VS 10-

11, Box 5: location of animal at blood draw – please indicate the animal’s usual residence -

stable/farm/ranch - and not a temporary or testing location.

• Approved EIA laboratories must only accept accurately and fully completed, official USDA approved 

forms with sample submissions.

• States and all other providers of EIA test forms must submit prospective forms to USDA VS for approval,

or switch to VS 10-11 or VSPS e10-11.
Contacts: rory.o.carolan@usda.gov ; NVSL.Coggins@usda.gov

Reduce 

confusion,

facilitate trade, 

compliance and 

trace-back.

changes to the 

official VS 10-11 will 

reflect the most 

current information 

and data points 

required. Other VS

approved EIA test 

forms which contain 

identical 

information/data 

points as the VS 10-

11 are official.

• AVIC may need to ensure adequate stock of paper VS 10-11, familiarize with VSPS e10-11, anticipate 

greater use of VSPS.

• Trading Partners should be made aware of the change occurring.

Allow 6 month 

waivers on use 

of existing EIA 

test forms.

Allow for 

business 

continuity

EIA test forms

existing at the time 

of publication of 

this document and 

State EIA test forms, 

both paper and 

electronic, will be

accepted as valid 

for submissions

until April 15 2020.

4.C.2 • Approved EIA laboratories current forms are waivered until April 15 2020.

• States and all other providers of EIA test forms are provided time to seek USDA VS approval for existing 

forms, modify non-compliant forms, or switch to VS 10-11 or VSPS e10-11. Prospective forms must be

submitted to VS for approval.

• The note at the bottom of the FEB2018 VS 10-11 (current form) regarding acceptance of old forms is an 

error and will be removed on the next printing.

Clarify the 

application 

process for 

initial laboratory 

approval.

Provide clarity 

and 

transparency.

New laboratory 

approval is based 

on laboratory’s 

ability to provide 

accurate and 

reliable testing and 

meet regulatory 

and reporting 

requirements, with 

appropriate 

facilities.

6.A • New applicants for an approved EIA laboratory must demonstrate adequate resources, facilities &

staffing. Must have knowledge of, and commitment to meeting the regulatory and reporting 

requirements.

• Approval requires consensus between AVIC and SAHO. 

• SAHO makes decisions based on the priorities of the State.
Contacts: rory.o.carolan@usda.gov ; NVSL.Coggins@usda.gov

Accept sample 

submissions 

only from 

Category II

accredited 

veterinarians.

The submitting 

veterinarian is 

knowledgeable

on regulatory 

requirements

and is 

accountable.

Approved EIA labs 

may accept only 

those samples 

submitted by a 

veterinarian who is 

federally accredited 

(Category II) and 

authorized to 

perform accredited 

duties in the State 

where the sample 

originated; or a

State or Federal 

animal health 

official.

6.F.1 • Category II submitting veterinarians must obtain and maintain Category II veterinary accreditation 

status.

• Category II submitting veterinarians must ensure they are authorized to perform those duties in the 

state the sample was obtained.

• Approved EIA laboratories may only accept samples from Category II accredited veterinarians

authorized to perform those duties in the state the sample was obtained. Check the accreditation status 

of your customers as they enter your system, at least annually and whenever you have any doubts about 

the accreditation status. The AVIC and the Equine Health Team will assist you as needed.

• SAHO’s may anticipate increased demand for State authorization.

• AVIC may anticipate increased demand for Veterinary Accreditation/authorizations.

Three ways lab personnel can determine accreditation status and states where an accredited veterinarian is 

authorized

1. Look up tool: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/ct_areavet

Go to check my accreditation status, Enter NAN and last name of veterinarian.

2. Call NVAP coordinator or your AVIC

Go to NVAP website for PDF list of coordinators for each area:

https://www.aphis.usda.gov/animal_health/vet_accreditation/downloads/nvap_coordinator.pdf

3. Use Veterinary Services Process Streamlining

https://vsapps.aphis.usda.gov/vsps/

Contact a Network Associate for information on how you can sign up for VSPS:

https://www.aphis.usda.gov/animal_health/prof_development/downloads/vsps_training_network_end_user.pdf

Accept only 

accurate and 

fully completed 

EIA test forms

and 

identification of 

animals.

Uniquely identify 

the animal to 

Require narrative

description of the 

equine; include: 

name, age, breed, 

color, gender, 

distinctive markings 

and, when present:

brands, tattoos, 

scars, cowlicks, 

blemishes, 

C.2

6.F.3

• Category II submitting veterinarians must accurately and fully complete the form according to 

instructions, and uniquely identify the animal. Blank fields are not acceptable.

• Approved EIA laboratories will only accept accurately and fully completed USDA approved forms.

• SAHO and AVIC officials will assist in compliance.

Clarification I: Before the laboratory distributes the final results the submitting veterinarian may request changes to 

the VS Form 10-11 - including address corrections or spelling mistakes acceptable to the laboratory. 

Alternatively, if a laboratory receives an incomplete form, it may, at its discretion, contact the submitting veterinarian 

to confirm they wish the laboratory to correct the omission, while the lab continuesto process the sample. However, 
Contacts: rory.o.carolan@usda.gov ; NVSL.Coggins@usda.gov

facilitate traceback and reduce

fraud.

regardless of other 

ID methods utilized. 

the laboratory will not release results until the form is properly completed. In all cases the laboratory must document 

and retain the request and changes with the laboratory copy of the VS Form 10-11.

Clarification II: RE: (F 11) “After distribution of the final results the information recorded on the original VS Form 10-

11 cannot be changed. In that case, take a new sample and submit a new form.”

The approved lab can accept a new, corrected, and serialized 10-11, created by the submitting veterinarian, if all the 

following are true:

• It is at the request of the submitting veterinarian

• The distributed copies can be collected and destroyed (paper or electronic record of serial number recorded 

as invalid)

• It can be accomplished and completed within 30 days of sample date.

• It is NOT for change in ownership!

• The changes do not substantially affect identification of animal. 

• Approved examples:

o Transposition of digits in a field

o Errors in recording microchip digits (NOT a new #!)

o Misspelling of name, use of barn name vs registered name

o Age error

• The lab must be comfortable with the corrections requested. If the lab is unwilling or uncomfortable they 

should request a new submission - it may be the easier solution.

• The corrections and the collection of distributed copies, must be recorded and made available for yearly 

inspection and audit.

Use the original date of results reported on the corrected form, in Laboratory Remarks Section note “Corrected 

Form—Original Serial #XXXXXX.” Keep a copy of both forms.

Clarification III: RE: (G1) “Negative Test Results: Laboratories should return official negative test results to the 

submitting veterinarian as soon as possible after completing the test. Laboratories can mail, email, fax, or otherwise 

electronically return results to the submitting veterinarian. However, if the veterinarian submitted the samples with 

OMB-approved, official paper VS 10-11 forms, then the laboratory must mail paper copies of PART 1 -

VETERINARIAN/SUBMITTER and PART 3 – OWNER to the submitter within 30 days. Some venues or importing 

countries may require these paper forms. Some practitioners may feel these forms are more secure and prefer their 

use.”
Contacts: rory.o.carolan@usda.gov ; NVSL.Coggins@usda.gov

The lab can create and distribute electronic copies to State and Federal officials, and to the customer, the submitting 

veterinarian. If, however, the lab’s customer submits a paper form and specifically asks for a paper form in return 

(either on every submission or on a single sample request) they must do so. As it suits their needs, labs may 

encourage customers to use an electronic submission format, commercial or otherwise. The VSPS system is free for 

practitioners and labs. 

•

Require 

confirmation of 

non-negative 

results at NVSL.

Provide 

consistent test 

procedures 

nationally. Gain

accurate and 

timely data. 

Provide test kit 

information to 

NVSL.

All samples testing 

positive, suspect, 

discrepant, or 

equivocal (as 

defined in the 

diagnostic test kit or 

NVSL protocols) in 

any of the licensed 

EIA diagnostic tests 

must be confirmed 

at NVSL

6.F.8 • Owners should plan on the possibility of a delay in receiving results.

• Category II submitting veterinarians - inform clients of the possibility of delay in obtaining final results.

• Approved EIA laboratories - have a plan in place for forwarding non-negative samples and for rapid 

turnaround of final results to owners.

• SAHOs - consider ramifications to their particular procedures.

• AVICs – anticipate increased reporting of non-negative results.

• NVSL - expect more referral samples and facilitate rapid turnaround.

Labs approved to run AGID are expected to continue to perform AGID on non-negative ELISA samples. Usually (and 

by prior agreement) the AGID lab will split the sample and send 2ml to NVSL, as they run their AGID. However, the 

ELISA lab still needs to report the non-neg. result to State and Federal officials. States that operate a 3 tier system 

can continue in that regard.

State officials are free to act, quarantine or direct disposition of the reactor animal based on the local AGID result, or

they may choose to wait until NVSL’s result is received. While AGID results are expected to be in concurrence, the 

NVSL result is the final result.

Require monthly 

summary data 

submission to 

Equine Health 

Team and State 

Animal Health 

Officials.

Provide accurate 

& timely 

national EIA data 

Laboratories must 

provide the Equine 

Health Team and 

the relevant State 

animal health 

official with timely

reports of monthly 

totals of negative 

and positive EIA 

tests grouped by 

test type (e.g. AGID 

6.H • Approved EIA laboratories must record accurate data and transmit it monthly to SAHO & Equine Health 

Team using approved format.

• SAHO will no longer serve as intermediary between laboratories and the Federal officials charged with 

generating national level data and reporting that data. This will increase accuracy and timeliness of 

national data. Accurate and prompt national data provides transparency for trade partners and 

facilitates trade.

• Federal officials have a plan in place to receive and manage data directly from the laboratories.
Contacts: rory.o.carolan@usda.gov ; NVSL.Coggins@usda.gov

directly to those 

who produce it, 

for use by 

decision makers.

and ELISA and origin 

state) using the 

format specified. 

Require 500 test 

annual 

minimum.

Maintain testing 

proficiency.

Laboratories that 

perform fewer than 

500 EIA tests 

annually should 

justify their 

approval/renewal 

and may be subject 

to additional 

inspections or 

proficiency panels 

initiated by NVSL or 

at the request of 

the State animal 

health official. 

6.A.1.h

6.I.1.d

6.I.2.d

6.J.5.b.7

6.M.10

Attach #1

• Approved EIA laboratories should document performing 500 tests annually to maintain proficiency. 

New applicants for an approved EIA laboratory should expect to meet the 500 test minimum.

• Approved EIA laboratories (or new applicants for an approved EIA laboratory that lack the expectation 

of meeting) the annual test minimum should be able to demonstrate proficiency, prepare for additional 

inspections and proficiency tests and the associated costs.

Require annual 

proficiency test 

(PT)

Demonstrate

testing 

proficiency.

Approved labs must 

pass a laboratory 

annual PT (1 test/ 

lab/yr.) regardless 

of how many 

approved EIA 

technicians there 

are. Labs that fail 

the annual PT are 

subject to 

withdrawal of 

approval. Failing an 

annual PT twice in 1 

year is grounds for 

immediate removal.

6.A.1.g

6.I.1.c

6.I.2.c

6.J.2

6.J.3

6.J.5.b.7

6.M.10

• Approved EIA laboratories must be able to demonstrate testing proficiency. It is incumbent on the 

laboratory to maintain current contact information with NVSL, respond to NVSL communications, and to 

request the annual proficiency test.
Contacts: rory.o.carolan@usda.gov ; NVSL.Coggins@usda.gov

Withdraw 

laboratory 

approval for 

failure to meet 

regulatory 

requirements.

Ensure reliable 

and accurate EIA 

testing and 

timely EIA 

information.

Laboratories must 

meet their 

requirements and 

regulatory 

obligations. Failure 

to meet these 

requirements will 

be grounds for 

withdrawal of 

laboratory approval.

6.M Approved EIA Laboratories must:

• Provide and maintain adequate and appropriate facilities.

• Provide NVSL trained personnel, who completed individual PT.

• Accept only samples submitted by a Category II accredited veterinarian authorized in the State where 

the sample was obtained.

• Accept only submissions with an accurate and fully completed official test form.

• Conduct all testing according to protocol.

• Use only diagnostic test kits approved by the USDA.

• Submit all non-negative samples to NVSL for confirmation. 

• Conduct all testing as official EIA testing; no screening or retesting.

• Meet annual laboratory proficiency (check) test (PT) requirements.

• Expect to perform at least 500 EIA tests per year. 

• Promptly report test results to State and Federal officials.

• Submit monthly summary data & provide adequate record keeping.

• Pass an annual inspection - required to maintain approval.

• Maintain current contact information and respond to official inquiries.

• Signed Director’s Agreement (VS 10-15).

Require annual 

inspection.

Maintain 

laboratory 

standards

Continued approval 

of laboratories will 

require an official 

inspection 

conducted by 

Federal personnel 

or a cooperative 

team of Federal and 

State personnel 

annually.

6.A.1.j

6.J.5

6.M.12

Attach#1.

• Approved EIA laboratories should schedule the annual inspections with their AVIC.

• AVICs should be familiar with the requirement, have appropriate plans for scheduling inspections and be 

familiar with the EMRS2 tool. 

Provide new 

inspection 

checklist.

Checklist is 

improved and more 

specific. There is 

increased emphasis 

Attach.#1 • Approved EIA Laboratories can anticipate, prepare for, and schedule annual inspections.

• State and Federal regulators have transparent and clear inspection guidelines.
Contacts: rory.o.carolan@usda.gov ; NVSL.Coggins@usda.gov

Clarify standards 

for maintaining 

approval

on documentation 

of requirements,

reporting and data 

submission 

requirements.

Clarification I: “Refrigerator ... with a thermometer capable of high/low temperature memory/recording, and ...

weekly high/low temperature record/log is kept.”

To comply use a thermometer that is: digital, with a resolution of at least 1°C, accuracy to ±2°C, Hi/Lo memory 

function. It should be maintained and calibrated according to the manufacturer’s instructions. The weekly log 

could be a paper notebook kept with the refrigerator.

NVSL is offering best practice recommendations to EIA Approved Labs about thermometers and associated 

calibration certificates. There is a spectrum of acceptable possibilities and we trust our inspectors to use 

professional judgment in deciding what will meet the requirement. Our Calibration Department also added that, 

given nothing was previously required of EIA Approved Labs concerning thermometers and associated calibration 

certificates.

Option C is a great start with the goal of phasing into Option A as the new guidance document and requirements 

become more familiar.

NVSL Calibration Department offered the following suggestions for thermometer calibration certificates:

Option A: Most PreferredCalibration from a fully Accredited ISO17025 Vendor, that provides an official (legal) Calibration Report. 

Option B: NiceCalibration provided by an ISO 9001 Vendor, with a Calibration Report and/or a sticker on the unit

Option C: Bare-bonesA calibration of some-sorts with a Calibration Report and/or a sticker on the unit

Clarification II: “Pipettes must be properly calibrated a minimum of every 12 months, preferably every 6 months ... 

Maintain pipette calibration records. “

To comply use a commercial servicer who completes multi-point calibration and provides an individually-numbered 

ISO/IEC 17025 Certificate of Calibration on each pipette serviced.